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510(k) Data Aggregation

    K Number
    K032594
    Device Name
    ONE DIMENSIONAL WATER PHANTOM, WP 1D
    Manufacturer
    WELLHOFER DOSIMETRIE
    Date Cleared
    2003-09-05

    (14 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELLHOFER DOSIMETRIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clinical Reference Dosimetry Phantom WP 1D is used to position various radiation detectors in water or air. It consists of a cubic tank and a precision onedimensional hand crank or motor driven servo. By design it is suitable to act as a phantom according to various dosimetric protocols (e.g. AAPM's TG-51 or IAEA's TRS-398). The device is intended to be used by experienced professionals entrusted with dosimetric functions only.
    Device Description
    The Clinical Reference Dosimetry Phantom WP 1D comprises a one-dimensional precision servomechanism attached to a Perspex (PMMA) water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs. The "Manual Version" consists of the basic phantom, equipped with a self-locking hand crank to move the detector. That hand crank is coupled to a battery powered, reset-able position indicator that displays the depth. The "SCU Version" consists of the basic phantom, equipped with a motor/potentiometer device to move the detector. An electronic servo control unit (SCU) consisting of a handheld Remote Control and a Motor Control unit is used to position the detector to a user definable or stored depth.
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    K Number
    K031634
    Device Name
    OMNIPRO I'MRT
    Manufacturer
    WELLHOFER DOSIMETRIE
    Date Cleared
    2003-08-29

    (94 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELLHOFER DOSIMETRIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the OmniPro I'mRT system is to: • verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment • verify the intensity maps during IMRT delivery prior to treatment • verify the absolute dose in given points for IMRT fields.
    Device Description
    The Scanditronix & Wellhöfer OmniPro I'mRT system is a system similar to Radiological Imaging Technology: RIT113 Film Analysis System FDA K935928 12/13/1993 The OmniPro I'mRT system and the marketed predicated product are radiotherapy quality assurance systems designed to measure dose, doseor intensity-distributions, to analyse these data and to compare the measurement data with calculated dose- or intensity-distributions, especially in the field of Intensity Modulated Radiotherapy. The OmniPro I'mRT system can consist of - software (herafter called OmniPro I'mRT) . - hardware supported by OmniPro I'mRT (like detector arrays, . filmscanning devices, single detectors, bodyphantoms for positioning and pacing of film and/or detectors or detector arrays).
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